Study of elderly with AMD having limited success
with Avastin-Lucentis injections finds Eylea improved vision for over 30
percent after six months; half had less fluid around retina

June 18, 2013 – Another of those worries right up
there near the top of the list for most senior citizens is age-related
macular degeneration. There is no cure for this eye disease that is the
leading cause of vision loss and blindness in older Americans. A new
study, however, seems to have discovered a drug that can at least ease
the vision problems.

Last year, the National Institutes of Health
reported that two drugs injected into the eyes, Avastin and Lucentis,
eased symptoms for sufferers, especially those in the advanced, “wet”
stage of the disease, when blood vessels in the eye become swollen and
leak fluids in the eye.

Yet for some AMD patients, the two drugs either
don’t work for long or fail to work at all. It’s a dead end for
treatment, or so it seemed.

Now, a team of ophthalmologists at the University
of Iowa has shown that a third drug, Eylea, can ease leaking and vision
problems for wet AMD patients.

In a study involving 31 AMD patients at the UI
Hospitals and Clinics, researchers report that half of the eyes treated
with Eylea had reduced fluid after three monthly injections. Moreover,
in some cases subsequent bimonthly injections with Eylea were deemed as
effective as monthly injections of Avastin and Lucentis over a similar
time period, meaning fewer visits by patients and less cost.

“The challenge has been treating patients who are
not very responsive to the first two drugs (Avastin and Lucentis). It
was assumed that they would not respond to anything,” says Vinit Mahajan,
assistant professor in the Department of Ophthalmology and Visual
Sciences at the UI and corresponding author on the paper published
online in the American Journal of Ophthalmology. “We are among the first
to show that this drug can be effective in patients that were resistant
to the first two drugs.”

The patients who tried out Eylea were 79 years old
on average. All had undergone eye injections with Avastin and Lucentis,
some dozens of times. After three monthly injections of Eylea, half of
the eyes treated (18) had less fluid in or around the retina. One in
five of those patients also had improved vision after the initial rounds
of treatment, according to the researchers, and nearly one in three had
improved vision after six months of treatment.

“What this means is if you have a patient who’s not
responding to Avastin or Lucentis, they need to try this new drug,” says
Mahajan, who has no financial stake in Eylea’s manufacturer, Regeneron
Pharmaceuticals, Inc. “There’s a very reasonable chance they’re going to
do better with it.”

All three drugs target swollen blood vessels in the
eye, albeit through different pathways. Of AMD patients who respond well
to Avastin (clinical name bevacizumab and manufactured by Genentech USA,
Inc.) and Lucentis (clinical name ranibizumab and also manufactured by
Genentech USA, Inc.), a minority develop a resistance to the drugs, and
the leaking in their eyes restarts, followed by recurring vision loss.
That development has sparked a wave of research to find other so-called
anti-VEGF medications that can be used for AMD treatment. Eylea
(clinical name aflibercept) is the latest to be approved for use.

The UI study was a pilot, designed to test Eylea’s
effectiveness in a small cohort for six months. Mahajan is quick to
point out further studies are needed to fully evaluate the new drug’s
efficacy, and he would like to see a trial directly comparing the drugs.
Until then, there is another option for AMD sufferers.

“We have a 50-50 chance of making previous
nonresponders better,” Mahajan says. “And 50-50 is a whole lot better
than zero.”

The first author on the paper is Benjamin Bakall, a
fellow associate in ophthalmology at the UI. Bakall, Mahajan, and James
Folk, an UI ophthalmologist, designed and conducted the research. Other
contributing authors, all from the UI, are H. Culver Boldt, Elliott Sohn,
Edwin Stone, and Stephen Russell.

The National Institutes of Health (grant no: K08EY
020530) funded the study.